510(k) K924476 ยท DKZ Enzyme Immunoassay, Amphetamine
THE TRIAGE II
| Applicant | Biosite Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Jan 22, 1993 |
| Received | Sep 3, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924476
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2012 | Alere San Diego Product Brand Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476), Triage Drugs of Abuse
Panel Plus TCA (K973784), & Triage Drugs of Abuse Panel Plus PPX (K014247)
Model Number: 90008, 92002, & 92 Terminated |
DIS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.